Validation CSV Expert GDIT R&D and MedicalIPSEN

Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.

Ipsen is strengthening its R&D and Medical Digital & IT organization to ensure the highest standards of compliance, quality, and audit readiness across its digital ecosystem.

We are looking for a Computer System Validation (CSV) Manager to act as the quality gatekeeper for IT systems supporting R&D activities. In this role, you will ensure that all computerized systems are fully compliant with regulatory requirements and internal quality standards, while enabling innovation and efficient delivery of digital solutions.

You will work at the intersection of IT, Quality, Regulatory, and business teams, ensuring that systems are validated, audit-ready, and aligned with global compliance frameworks.

Your key responsibilities

• Define and lead the CSV strategy for R&D IT systems, ensuring compliance with global regulations (GxP, FDA, etc.).
• Act as the guarantor of system validation and compliance, ensuring all systems are audit-ready at all times.
• Oversee the full validation lifecycle (URS, FS/DS, IQ/OQ/PQ, documentation, periodic reviews).
• Ensure high-quality validation documentation, aligned with regulatory expectations and internal standards.
• Lead audit and inspection readiness, acting as a key contact for internal and external audits.
• Support IT and project teams in embedding validation requirements into system implementations and changes.
• Manage change control processes and assess validation impacts across system evolutions.
• Collaborate closely with IT QA, Regulatory, Quality, and business stakeholders to ensure alignment and compliance.

Your profile & expertise

• 6-8 years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
• Strong knowledge of regulatory frameworks (GxP, FDA 21 CFR Part 11, Annex 11, GAMP5).
• Solid experience managing the validation lifecycle and audit/inspection processes.
• Experience working with R&D systems (e.g., Veeva, LIMS, ELN).
• Ability to combine strategic vision with hands-on execution.
• Strong stakeholder management skills in cross-functional and regulated environments.
• High level of rigor in documentation and compliance practices.
• Ability to communicate with regulatory authorities and audit teams.
• Strong influencing and transversal leadership skills.
• Fluent in English.

Why join Ipsen?

• A critical and high-impact role ensuring compliance of R&D digital systems.
• Strong exposure to regulatory, quality, and IT environments.
• A strategic position at the core of innovation and compliance balance.
• A collaborative and international environment focused on patient impact and excellence.